FDA Intel

Advanced Pharmaceutical Technology, Inc.

Form 483 issued August 1, 2024 · Elmsford, New York

Inspection
Jul 10 – Aug 1, 2024
Investigator
Gam S. Zamil
Observations
8
Pages
12
FEI number
3009963974

In short: On August 1, 2024, FDA issued a Form 483 with 8 observations to Advanced Pharmaceutical Technology, Inc. in Elmsford, New York (FEI 3009963974) after an inspection that ran Jul 10 – Aug 1, 2024. The investigator was Gam S. Zamil. Most observations concern production and laboratory controls; the most-cited regulation is 21 CFR 211.22 (responsibilities of quality control unit).

At a glance

Production and laboratory controls account for 5 of 8 observations.

Production3
Laboratory controls2
Materials2
Quality system1

What FDA observed

Preview: the opening words of each observation
  1. 01
    21 CFR 211.165(a)

    Testing and release of ding product for distribution do not include appropriate laboratory determination of satisfactoiy…

  2. 02
    21 CFR 211.22(a)21 CFR 211.22(A)

    The quality control unit lacks responsibility for approving or rejecting ding products manufactured, processed, packed and…

  3. 03
    21 CFR 211.100(a)

    Your firm failed to establish adequate written procedures for production and process controls designed to assure…

  4. 04
    21 CFR 211.113(b)

    Procedures designed to prevent microbiological contamination of ding products purporting to be sterile did not include…

4 more observations

Plus the full detail behind each one, exactly as FDA wrote it.

Get the full 483

This inspection in context

The investigator

Gam S. Zamil

18 documents · 2016–2024

Cites 211.166 (stability testing) more than any other section. Most of their documents are for sites in New York.

The firm

Advanced Pharmaceutical Technology, Inc. history

All 5 documents on file for this site, in date order, with what was cited at each inspection.

Similar 483s

Other sites cited under 211.165(a)

See how FDA wrote the same problem up elsewhere.

Questions about this 483

What did FDA find at Advanced Pharmaceutical Technology, Inc.?

FDA listed 8 observations on this Form 483, mostly about production, laboratory controls and materials. The most-cited regulation is 21 CFR 211.22 (responsibilities of quality control unit). The opening words of each observation are shown on this page.

Who inspected Advanced Pharmaceutical Technology, Inc.?

Gam S. Zamil is named on this Form 483, for the inspection of Jul 10 – Aug 1, 2024. Each investigator has a profile showing what they cite most.

When was Advanced Pharmaceutical Technology, Inc. inspected by FDA?

The inspection ran Jul 10 – Aug 1, 2024, and the Form 483 is dated August 1, 2024.

How do I get the full Form 483 for Advanced Pharmaceutical Technology, Inc.?

Download the original PDF from FDA Intel for $99, with no subscription. Your first Form 483 or letter is on us. You also get an invoice PDF with the order.

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